To prove a generic drug is as safe and effective as the branded version, pharmaceutical companies have to hand over upwards of 1,000 doses of the product to a generic developer. But if the manufacturer creating the generic drug cannot get its hands on enough sample, the development and testing process slows down. It could […]
Novartis
Update: Novartis paid more than $1m to consulting company linked to Trump attorney Michael Cohen
Updated 5/9 to include new information about Novartis’ payments to Essential Consultants. Novartis (NYSE:NVS) found itself in the middle of a national scandal today after it was revealed that the drugmaker paid more than $1 million to a consulting firm linked to President Donald Trump’s personal attorney, Michael Cohen. The shell company, Essential Consultants, was used by […]
Following first profitable quarter, Vericel’s CEO looks to grow portfolio of autologous cell therapy products
In its latest financial results, Cambridge, Mass.-based Vericel (NSDQ:VCEL) saw sales climb 60% for its permanent skin-replacement product, Epicel, designed for patients with severe burns. Sales for its autologous cellular scaffold, Maci, were up 20% following its launch to the commercial market. Vericel’s growing product adoption helped to fuel the company’s first profitable quarter, according to […]
Pear Therapeutics, Sandoz ink deal for prescription digital therapeutics
Pear Therapeutics revealed yesterday that it agreed to deal commercialization rights of its digital therapeutics to Novartis (NYSE:NVS) division Sandoz. The company’s reSET substance use disorder therapy became the first prescription digital therapeutic approved by the FDA in September last year. reSET-O, a digital therapeutic designed for people suffering from opioid use disorder, is under review […]
Novartis, Harvard team up to develop immunotherapy drug-delivery systems
Novartis (NYSE:NVS), Harvard University and the Dana-Farber Cancer Institute are teaming up to develop the next generation of implantable and injectable biomaterials designed to delivery immunotherapies, the group reported today. Researchers from Harvard’s Wyss Institute for Biologically Inspired Engineering have worked for years to create systems that provide targeted, sustained delivery of immuno-oncology products. Now, Novartis […]
Sandoz wins FDA nod for generic, injectable MS drug
Sandoz said today that the FDA has approved its Glatopa glatiramer acetate injection as a generic version of Copaxone to treat relapsing forms of multiple sclerosis. The therapy, which is given three days per week, is administered using the Glatopaject injection device. The 20 mg/mL version of the MS treatment has been available in the […]
Rani Therapeutics nabs $53m for robotic pill injection tech
Rani Therapeutics has raised $53 million to support manufacturing as it gears up for clinical trials of its robotic pill technology. New investors like GeneScience Pharmaceuticals and Shire (NSDQ:SHPG) joined existing investors like Alphabet’s GV, Novartis (NYSE:NVS) and AstraZeneca (NYSE:AZN). Rani Therapeutics, an InCube Lab spin-out started in 2012, has developed a capsule that delivers an intestinal injection […]
FDA rejects Novartis’ Advair generic, leaving GSK without rival
GlaxoSmithKline (NYSE:GSK) was granted a temporary win today after Novartis‘ (NYSE:NVS) Sandoz unit reported that the FDA rejected its application for a generic version of the company’s blockbuster lung treatment, Advair. The regulatory agency reportedly told Novartis that it needs to submit additional clinical data before the FDA can make its final decision. GSK said in […]
Study: Long-term use of inhaled corticosteroids may heighten risk of bone fractures in COPD patients
Researchers reported this month that in men and women with chronic obstructive pulmonary disease, long-term use of inhaled corticosteroids may be linked to an increased risk of bone fractures. Previous research has shown that the inhaled drugs, used to treat COPD, impact bone mineral density based on the dose of the corticosteroid, especially in post-menopausal […]
NASA scientists take on muscular atrophy with drug-loaded implant
Scientists aboard the International Space Station plan to study if a drug-eluting implant can prevent, slow or even turn back the muscular breakdown observed in astronauts when they fly for an extended period of time. The investigation is designed to test the efficacy of a drug and a nano-channel drug-delivery system in a space-bound mouse […]
